MedTrace Logo

Transoral Incisionless Fundoplication in Post-POEM GERD

NCT04770441 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7

Last updated 2023-08-18

No results posted yet for this study

Summary

POEM (per oral endoscopic myotomy) is effective for the treatment of swallowing disorders but can induce acid reflux. If acid reflux remains untreated in this situation, it can lead to significant problems. Thus, minimizing abnormal acid exposure after POEM is very important. Typically, this is done with acid suppression medications such as Prilosec or Nexium. However, long term acid suppression medication has been linked to possible long-term complications. Transoral incisionless fundoplication (TIF) has been approved for the treatment of reflux, but its use in reflux after POEM has not been investigated in detail. We hypothesize TIF will be able to decrease the amount of acid reflux in to the esophagus, thereby allowing patients to remain off of acid suppression medications.

Once enrolled into the study, you will undergo the POEM procedure. 3 months after the procedure we will assess for abnormal reflux via questionnaires and diagnostic testing as part of the standard management post POEM. If there is evidence of abnormal reflux, the TIF procedure will be performed. 3 months after the TIF, you will have similar testing again to document resolution in abnormal acid reflux.You will be followed for 12 months as part of the study. If at the 3 month mark, there is no evidence of abnormal reflux, you will neither be placed on PPI nor undergo TIF and will be followed for 12 months to assess for abnormal reflux

Conditions

  • Swallowing Disorders
  • Achalasia
  • Outlet Obstruction, Gastric
  • Diffuse Esophageal Spasm

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-17
Primary Completion
2022-10-15
Completion
2023-06-03

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04770441 on ClinicalTrials.gov